(478 days)
The Tissue Spectroscope is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in these parameters provide information on tissue metabolic activity.
The Tissue Spectroscope is a device that carries out various in-vivo, spectroscopic measurements. It is a combination device consisting of an NADH Fluorometer and a Laser Doppler Flowmeter. The Tissue Spectroscope is used to transmit radiation at a known wavelength through tissue and to measure the fluorescence of NADH and the intensity of light reflected from the tissue, including the Doppler shift arising from the moving red blood cells. The Tissue Spectroscope measures the following three parameters: 1. Mitochondrial NADH fluorescence at 420 nm to 480 nm. 2. Doppler shifted laser light (325nm) reflected from moving blood cells. 3. Total backscattered light (325nm) reflected from the tissue. This parameter allows for correction of the NADH fluorescence measurement due to changes in tissue blood volume. These three parameters contain information, respectively, pertaining to the redox state of mitochondrial NAD/NADH of the tissue, microvascular blood flow in the tissue and total blood volume of the tissue. Changes in these values reflect changes in the balance between oxygen supply and oxygen demand.
The provided document is a 510(k) summary for the Vital Medical Ltd., Tissue Spectroscope, cleared on November 17, 2000. It details the device's description, indications for use, and a claim of substantial equivalence to predicate devices. However, this document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or any comparative effectiveness studies.
The document is a regulatory approval notice, not a clinical study report. It focuses on the substantial equivalence argument for regulatory clearance rather than providing detailed performance data from specific studies.
Therefore, I cannot populate the requested sections based on the provided text. The document states:
- Name of the Device: Tissue Spectroscope
- Indications for Use: The Tissue Spectroscope is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in these parameters provide information on tissue metabolic activity.
- Predicate Devices: The Tissue Spectroscope is substantially equivalent to a combination of the Laserflow BPM2, the INVOS 3100A Cerebral Oximeter and the LKB-Wallac 1230 Arcus Fluorometer.
- Claim of Equivalence: "The differences between the systems raise no new issues of safety or effectiveness." and "We have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
To answer the prompt, information from a separate clinical study report or a more detailed section of the 510(k) application (which is not included here) would be required.
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NOV 1 7 2000
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter:
Vital Medical Ltd., P.O. Box7292 Petach Tikva 49170, Israel Tel: +972.3.921-3845; Fax: +972.3.921-3847;
Name of the Device: Tissue Spectroscope
- · Predicate Devices: The Tissue Spectroscope is substantially equivalent to a combination of the Laserflow BPM2, the INVOS 3100A Cerebral Oximeter and the LKB-Wallac 1230 Arcus Fluorometer.
Description of the Device: The Tissue Spectroscope is a device that carries out various in-vivo, spectroscopic measurements. It is a combination device consisting of an NADH Fluorometer and a Laser Doppler Flowmeter. The Tissue Spectroscope is used to transmit radiation at a known wavelength through tissue and to measure the fluorescence of NADH and the intensity of light reflected from the tissue, including the Doppler shift arising from the moving red blood cells.
The Tissue Spectroscope measures the following three parameters:
-
- Mitochondrial NADH fluorescence at 420 nm to 480 nm.
-
- Doppler shifted laser light (325nm) reflected from moving blood cells.
-
- Total backscattered light (325nm) reflected from the tissue. This parameter allows for correction of the NADH fluorescence measurement due to changes in tissue blood volume.
These three parameters contain information, respectively, pertaining to the redox state of mitochondrial NAD/NADH of the tissue, microvascular blood flow in the tissue and total blood volume of the tissue. Changes in these values reflect changes in the balance between oxygen supply and oxygen demand.
The differences between the systems raise no new issues of safety or effectiveness.
July 25.99
Date
A. Mayevsky
Prof. Avraham Mayevsky, President
Tissue Spectroscope 510(k) Application
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2000
VITAL Medical Ltd. c/o Bruce F. Mackler, Ph.D. Heller Ehrman White & McAuliffe 815 Connnecticut Ave N.W. Suite 200 Washington, D.C. 20006-4004
K992529 Re: Trade Name: Tissue Spectroscope Requlatory Class: II (two) Product Code: DPW, DQA, KHO Dated: August 29, 2000 Received: August 29, 2000
Dear Dr. Mackler:
We have reviewed your Section 510(k) notification of intent to market we nave referenced above and we have determined the device is the device foreignealent (for the indications for use stated in the Subscancially of additionarketed predicate devices marketed in encrosure, co regulir to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls eno golors of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device add Eronar School of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Bruce F. Mackler, Ph.D.
This letter will allow you to begin marketing your device as described inis lecter will arrow you co boys. .......................................................................................................................................... In your 310(x) premarker noto a legally marketed predicate device equivalence or your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro reguration (ir ces), please contact the Office of Compliance at Graghosere actrossy promally, for questions on the promotion and (301) 394-4040. Addrefonally) 201 questics the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 807.97) . MSbranding by responsibilities under the Act may Ocher general Information of Small Manufacturers Assistance at its be obtained from the bivior. (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
James E. Dillard J
on James E. Dillard III Director
Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known)_K 992 529
Device Name_ The Tissue Spectroscope
Indications For Use:
The Tissue Spectroscope is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in these parameters provide information on tissue metabolic activity.
(for Miriam Provost
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
k Number
vision Sign-Off) (D) "sinn of Cardiovascut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over The Counter Use
(Optional Format 1-2-96)
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Tissue Spectroscope 510(k) Application
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).